ETHILONRecalls & reported problems across all models
Ethicon, LLC · 133 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ETHILON model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,680
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls
- 1
We found 133 models of ETHILON by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 1,680 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Sep 30, 2026 — classified as 72 injuries, 1,608 malfunctions.
The most frequently reported specific device problem is “Material Separation” (716 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ETHILON recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 20, 2024Open, Classified
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-1097-2025 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported ETHILON problems
Device problems
- Material Separation716
- Break601
- Appropriate Device Problem Term/Code Not Available162
- Material Twisted/Bent86
- Material Deformation81
- Adverse Event Without Identified Device or Use Problem54
- Defective Component45
- Device Contaminated During Manufacture or Shipping41
Patient problems
- No Clinical Signs, Symptoms or Conditions1,303
- No Consequences Or Impact To Patient282
- Unspecified Infection44
- Insufficient Information20
- Wound Dehiscence14
- Hemorrhage/Blood Loss/Bleeding11
- Foreign Body In Patient7
- Not Applicable6
ETHILON models
133 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- ETHILON 697GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHILON 698GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- ETHILON 699GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall34 reports
- ETHILON 1669HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall30 reports
- ETHILON 661HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall12 reports
- ETHILON 698HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE58 reports
- ETHILON 1667GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE53 reports
- ETHILON 628HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall3 reports
- ETHILON F2416HSuture, nonabsorbable, synthetic, polyamide1 recall0 reports
- ETHILON EH7827BHSuture, nonabsorbable, synthetic, polyamide1 recall0 reports
- ETHILON EH7797BHSuture, nonabsorbable, synthetic, polyamide1 recall0 reports
- ETHILON 1667HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE47 reports
- ETHILON 1865GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE45 reports
- ETHILON 662GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE38 reports
- ETHILON 1698GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE37 reports
- ETHILON 662SLHSuture, nonabsorbable, synthetic, polyamide37 reports
- ETHILON 1666HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE36 reports
- ETHILON 9000GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE36 reports
- ETHILON 664HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE28 reports
- ETHILON 1663GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE26 reports
- ETHILON F2413HSuture, nonabsorbable, synthetic, polyamide25 reports
- ETHILON 1661GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE23 reports
- ETHILON 1663HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE22 reports
- ETHILON 1855GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE21 reports
- ETHILON 2809GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE19 reports
- ETHILON 585HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE18 reports
- ETHILON 7718GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE17 reports
- ETHILON 669HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE16 reports
- ETHILON 663HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE15 reports
- ETHILON 9033GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE15 reports
- ETHILON 1162HSuture, nonabsorbable, synthetic, polyamide15 reports
- ETHILON W2808Suture, absorbable, natural14 reports
- ETHILON 1865HSuture, nonabsorbable, synthetic, polyamide14 reports
- ETHILON F2417HSuture, nonabsorbable, synthetic, polyamide14 reports
- ETHILON F2440HSuture, nonabsorbable, synthetic, polyamide14 reports
- ETHILON 1667ZHSUTURE, ABSORBABLE, NATURAL14 reports
- ETHILON 642GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE12 reports
- ETHILON 663GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE12 reports
- ETHILON 7756GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE12 reports
- ETHILON F2435HSuture, nonabsorbable, synthetic, polyamide12 reports
- ETHILON 2819GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE11 reports
- ETHILON 662HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE11 reports
- ETHILON 1698HSuture, nonabsorbable, synthetic, polyamide11 reports
- ETHILON 1647GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- ETHILON 2810GSuture, absorbable, natural10 reports
- ETHILON 691GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- ETHILON 699HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- ETHILON 9001GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- ETHILON U7003Suture, absorbable, natural10 reports
- ETHILON 1666GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE9 reports
- ETHILON F2414HSuture, nonabsorbable, synthetic, polyamide9 reports
- ETHILON F2415HSuture, nonabsorbable, synthetic, polyamide9 reports
- ETHILON 653HSuture, nonabsorbable, synthetic, polyamide9 reports
- ETHILON 1674HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE8 reports
- ETHILON 667GSuture, absorbable, natural8 reports
- ETHILON 690GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE8 reports
- ETHILON 9003GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE8 reports
- ETHILON 1692GSuture, nonabsorbable, synthetic, polyamide7 reports
- ETHILON 2808GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE7 reports
- ETHILON 2894GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE7 reports
- ETHILON 689GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE7 reports
- ETHILON U7000Suture, nonabsorbable, synthetic, polyamide6 reports
- ETHILON 1668GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- ETHILON 1864GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- ETHILON 1966GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- ETHILON 2892GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- ETHILON 697HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- ETHILON F24022HSuture, nonabsorbable, synthetic, polyamide6 reports
- ETHILON 1662GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- ETHILON 2870GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- ETHILON 593HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- ETHILON 664GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- ETHILON 7707GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- ETHILON 1673HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON 1854GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON 2813GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON 2829GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON 661GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON L886TSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- ETHILON 1628HSuture, nonabsorbable, synthetic, polyamide4 reports
- ETHILON W1756Suture, absorbable, natural4 reports
- ETHILON W738GSuture, nonabsorbable, synthetic, polyamide4 reports
- ETHILON 1674BHSuture, nonabsorbable, synthetic, polyamide4 reports
- ETHILON 1665GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- ETHILON 1856GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- ETHILON 2898GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- ETHILON 668GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- ETHILON EH7563HSuture, nonabsorbable, synthetic, polyamide3 reports
- ETHILON EH7942BHSuture, nonabsorbable, synthetic, polyamide3 reports
- ETHILON F3206BHSuture, nonabsorbable, synthetic, polyamide3 reports
- ETHILON 1611GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1629HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1671HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1691HSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1714GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1866GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 1894GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 2820GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- ETHILON 7717GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
Recent ETHILON adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948619 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948618 ↗MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture split from the needle. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946795 ↗InjurySep 29, 2026Material Separation
Patient problems: Insufficient Information
MAUDE report 50932590 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923482 ↗MalfunctionSep 28, 2026Material Frayed
It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916700 ↗MalfunctionSep 28, 2026Material Frayed
It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916699 ↗MalfunctionSep 28, 2026Material Frayed
It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916697 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916527 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916526 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902753 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902740 ↗InjurySep 25, 2026Break
Patient problems: Insufficient Information
MAUDE report 50892648 ↗InjurySep 25, 2026Break
Patient problems: Insufficient Information
MAUDE report 50892646 ↗InjurySep 25, 2026Break
Patient problems: Insufficient Information
MAUDE report 50892645 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 recalls
- PROLENE358 models · 7,292 reports · 2 recalls
- PDS224 models · 2,635 reports · 10 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
- PERMA-HAND77 models · 664 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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